Cleared Traditional

K162508 - KerraCel Ag Gelling Fiber Silver Dressing

K162508 · Exciton Technologies, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2017
Decision
158d
Days
-
Risk

K162508 is an FDA 510(k) clearance for the KerraCel Ag Gelling Fiber Silver Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Exciton Technologies, Inc. (Edmonton, CA). The FDA issued a Cleared decision on February 13, 2017 after a review of 158 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Exciton Technologies, Inc. devices

Submission Details

510(k) Number K162508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2016
Decision Date February 13, 2017
Days to Decision 158 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 115d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 212
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